Laparoscopic instrument and trocar system and related surgical method

ABSTRACT

Laparoscopic instruments and cannulas are provided for performing laparoscopic procedures entirely through the umbilicus. Generally S-shaped laparoscopic instruments placed through the C-shaped trocar sleeves or through the cannula and instrument holder unit provide markedly improved degrees of instruments&#39; freedom during trans-umbilical laparoscopic procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/668,542 filed on Sep. 23, 2003 by Piskun, entitled “LAPAROSCOPICINSTRUMENT AND TROCAR SYSTEM AND RELATED SURGICAL METHOD”, the entirecontents of which are incorporated by the reference herein.

FIELD OF INVENTION

The present invention relates to the surgical instruments, andparticularly to laparoscopic instruments, which facilitate theperformance of laparoscopic procedures entirely through the umbilicus.

BACKGROUND

Abdominal laparoscopic surgery gained popularity in the late 1980's,when benefits of laparoscopic removal of the gallbladder overtraditional (open) operation became evident. Reduced postoperativerecovery time, markedly decreased post-operative pain and woundinfection, and improved cosmetic outcome are well established benefitsof laparoscopic surgery to perform an operation utilizing smallerincisions of the body cavity wall.

Laparoscopic procedures generally involve insufflation of the abdominalcavity with CO₂ gas to a pressure of around 15 mm Hg. The abdominal wallis pierced and a 5-10 mm in diameter straight tubular cannula or trocarsleeve is then inserted into the abdominal cavity. A laparoscopictelescope connected to an operating room monitor is used to visualizethe operative field, and is placed through (one of the trocar sleeve(s).Laparoscopic instruments (graspers, dissectors, scissors, refractors,etc.) are placed through two or more additional trocar sleeves for themanipulations by the surgeon and surgical assistant(s).

Recently, so called “mini-laparoscopy” has been introduced utilizing 2-3mm diameter straight trocar sleeves and laparoscopic instruments. Whensuccessful, mini-laparoscopy allows further reduction of abdominal walltrauma and improved cosmesis. However, instruments used formini-laparoscopic procedures are generally more expensive and fragile.Because of their performance limitations, due to their smaller diameter(weak suction-irrigation system, poor durability, decreased videoquality), mini-laparoscopic instruments can generally be used only onselected patients with favorable anatomy (thin cavity wall, fewadhesions, minimal inflammation, etc.). These patients represent a smallpercentage of patients requiring laparoscopic procedures. In addition,smaller, 2-3 mm, incisions may still cause undesirable cosmetic outcomesand wound complications (bleeding, infection, pain, keloid formation,etc.).

Since the benefits of smaller and fewer body cavity incisions areproven, it would be attractive to perform an operation utilizing only asingle incision in the navel. An umbilicus is the thinnest and leastvascularized, and a well-hidden, area of the abdominal wall. Theumbilicus is generally a preferred choice of abdominal cavity entry inlaparoscopic procedures. An umbilical incision can be easily enlarged(in order to eviscerate a larger specimen) without significantlycompromising cosmesis and without increasing the chances of woundcomplications. The placement of two or more standard (straight) cannulasand laparoscopic instruments in the umbilicus, next to each other,creates a so-called “chopstick” effect, which describes interferencebetween the surgeon's hands, between the surgeon's hands and theinstruments, and between the instruments. This interference greatlyreduces the surgeon's ability to perform a described procedure.

Thus, there is a need for instruments and trocar systems which allowlaparoscopic procedures to be performed entirely through the umbilicus,while at the same time reducing or eliminating the “chopstick effect”. Alaparoscopic procedure performed entirely through the umbilicus, usingthe laparoscopic instruments and trocar system according to anembodiment of the present invention, allows one to accomplish thenecessary diagnostic and therapeutic tasks while further minimizingabdominal wall trauma and improving cosmesis.

SUMMARY OF THE INVENTION

A general object of the present invention is to provide a laparoscopicinstrument and an instrument or cannula holder for use in theperformance of laparoscopic procedures, for instance, entirely throughthe umbilicus.

A more specific object of the present invention is to provide alaparoscopic instrument, which may markedly increase the workspacebetween the laparoscopic instruments and between the hands of thesurgeon where more than one instrument shaft is inserted through thesame opening in the patient's abdominal wall.

A more general object of the present invention is to provide alaparoscopic instrument that has enhanced operational flexibility tofacilitate the performance of laparoscopic surgical procedures.

A related object of the present invention is to provide a cannula orinstrument holder utilizable in combination with such a laparoscopicinstrument to facilitate the performance of a laparoscopic procedurethrough a single opening in the patient's abdominal wall, for instance,in the patient's umbilicus.

Another object of the present invention is to provide generally S-shapedlaparoscopic instruments.

In one embodiment of the present invention, a stand-alone laparoscopicmedical instrument insertable through a laparoscopic trocar sleevecomprises an elongate shaft, an operative tip disposed at one end of theshaft, and an actuator disposed at an opposite end of the shaft, theactuator being operatively connected to the operative tip via the shaftfor controlling the operation of the operative tip. The shaft has aproximal end portion and middle portion and a distal end portion, atleast the distal end portion being independently bendable to form a Cshape. The distal segments of the shaft are rotatable about alongitudinal axis at least one location along the instrument's shaft,preferably at the operative tip or proximal to the operative tip.

Pursuant to additional features of the present invention, the distal endportion of the instrument shaft is continuously bendable into a smoothlycurved C-shaped configuration, while a lock is operatively connected tothe shaft for releasably maintaining the C-shaped curved configuration.Moreover, the distal end portion may be provided with an articulatedjoint, whereby the distal end portion is swingable relative to themiddle portion of the shaft. The proximal end portion may also beindependently bendable to form a C shape.

In a further embodiment of the present invention, a stand-alonelaparoscopic medical instrument insertable through a laparoscopic trocarsleeve comprises an elongate shaft, an operative tip disposed at the oneend of the shaft, and an actuator disposed at an opposite end of theshaft. The actuator is operatively connected to the operative tip viathe shaft for controlling the operation of the operative tip. The shafthas a proximal end portion and a distal end portion, the distal endportion being continuously bendable to form a smoothly curved C shape.The distal end portion is connected to the proximal end portion via anarticulated joint, whereby the distal end portion may be laterally swungwith the reference to the proximal end portion.

In this further embodiment of the invention, the proximal end portion ofthe instrument shaft may include a rigid segment connected to the distalend portion via the articulated joint. The proximal end portion mayadditionally include a flexible segment connected to the rigid segmenton a side thereof opposite the distal end portion, the actuator beingconnected to a free end of the flexible segment, opposite the rigidsegment.

A stand-alone laparoscopic medical instrument insertable through alaparoscopic trocar sleeve comprises, in accordance with anotherembodiment of the present invention, an elongate shaft, an operative tipdisposed at one end of the shaft, and a manual actuator disposed at anopposite end of the shaft, the manual actuator being operatively coupledto the operative tip via the shaft. A first mechanism is operativelyconnected to the shaft for bending a proximal portion of the shaft in afirst direction, while a second mechanism is operatively connected tothe shaft for bending a distal portion of the shaft in a seconddirection different from the first direction, whereby the shaft assumesa shape with a plurality of differently shaped segments.

The shaft has a longitudinal axis at the one end, and the instrumentfurther comprises a rotation mechanism operatively connected to theshaft for rotating the operative tip about the axis.

Pursuant to another feature of this other embodiment of the invention,first locking element is operatively connected to the first mechanismand a second locking element is operatively connected to the secondmechanism, whereby the proximal portion and the distal portion may bemaintained as the differently shaped segments. Where the proximalportion and the distal portion are bendable by the first mechanism andthe second mechanism in a common plane, the instrument may furthercomprise an additional mechanism operatively connected to the shaft forbending the distal portion of the shaft in an additional direction outof the plane.

Where the proximal portion of the shaft assumes a first C-shapedconfiguration in response to the operation of the first mechanism andthe distal portion of the shaft assumes a second C-shaped configurationin response to operation of the second mechanism, the C-shapedconfigurations may face opposite sides of the shaft.

A laparoscopic medical instrument comprises, in accordance with anadditional embodiment of the present invention, an elongate flexibleshaft, an operative tip disposed at one end of the shaft, and a manualactuator disposed at an opposite end of the shaft, the manual actuatorbeing operatively coupled to the operative tip via the shaft, a firstbending mechanism being operatively connected to the shaft for curving aproximal portion of the shaft in a first direction, and a second bendingmechanism being operatively connected to the shaft for curving a distalportion of the shaft in a second direction different from the firstdirection, whereby the shaft assumes a shape with a plurality of arcuatesegments.

The instrument of this additional embodiment of the invention mayadditionally comprise a rotation mechanism operatively connected to theshaft for rotating the operative tip about the axis, a first lockingelement operatively connected to the first bending mechanism and asecond locking element operatively connected to the second bendingmechanism. The bending mechanisms each include a manual actuator mountedto the shaft at the other end thereof.

A holder for cannulas and instruments in laparoscopic surgicaloperations comprises, in accordance with the present invention, a platemember having a surrounding edge and a wall surrounding the platemember, the wall being connected to the plate member all along the edge.The wall has a longitudinal axis, while the plate member extendssubstantially transversely to the axis. The plate member may be providedwith a plurality of apertures for receiving respective elongatelaparoscopic surgical members.

The height dimension of the wall of the cannula and instrument holder isat least as great as, and preferably substantially greater than, theheight dimension of the plate member. The wall may have at least one endportion extending as a flange to the plate member. In at least oneembodiment of the cannula and instrument holder, the wall has two endportions extending as endless flanges to the plate, with the platemember being located at one end of the wall and with the plate memberand the wall forming a cup shape.

The inner diameter of the wall of the cannula and instrument holder atan end opposite the plate member is preferably larger than the innerdiameter of the wall at the plate member, so that the cannula andinstrument holder has a flared or tapered profile.

Pursuant to further features of the present invention, the plate memberand/or the wall of the cannula and instrument holder is inflatable,while the plate member is provided at the apertures with extensionselongating the apertures. The height of the plate member, in a directionparallel to the axis of the cannula and instrument holder, is at leastas great as the height of the extensions. Preferably, the plate memberis flexible.

Pursuant to another feature if the present invention, where theapertures in the plate member of the cannula and instrument holder havea longitudinal dimension extending generally parallel to the axis, atleast one of the apertures has a curvilinear or arced shape along thelongitudinal dimension of the one of the apertures.

The wall of the cannula and instrument holder may be flexible and atleast partially curved in a direction parallel to the axis of theholder.

At least one of the plate member and the wall of the cannula andinstrument holder is provided with a gas channel for the introductionfan insufflation gas into a patient. In addition, the wall isadvantageously provided with an anchoring element for securing theholder to a patient. The anchoring element is preferably taken from thegroup consisting of a hook and an eyelet.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a conventional laparoscopic instrumentinserted through a conventional straight trocar sleeve or cannula.

FIG. 2A is a side view and FIG. 2B is an end view of an exemplaryembodiment of a flexible C-shaped trocar sleeve or cannula. FIG. 2C isan exemplary embodiment of an S-shaped instrument.

FIG. 3 is a schematic view of an exemplary embodiment of an S-shapedlaparoscopic instrument inserted through a C-shaped flexible trocarsleeve or cannula.

FIG. 4A is a lateral view and FIG. 4B is a perspective view of anexemplary inflatable unit with multiple C-shaped trocar sleeve orcannulas incorporated within the unit.

FIG. 5A is a non-inflated lateral view and FIG. 5B is an inflatedlateral view of an exemplary inflatable C-shaped trocar sleeve orcannula having a balloon-like structure within the hollow body of thecannula.

FIG. 6 is a lateral view of an exemplary angulated needle with two sharpends and a thread attached at the angle of the needle.

FIG. 7 is a lateral view of an exemplary angulated needle having a longsegment with a pointed end on one side of the angle and a short segmenthaving attached thread on the other side of the angle.

FIG. 8 is a cross-sectional view of an exemplary embodiment of aninflatable unit having multiple cannulas incorporated within the unit.

FIG. 9 is a schematic side elevational view of a laparoscopic instrumentin accordance with the present invention.

FIG. 10 is a schematic side elevational view of another laparoscopicinstrument in accordance with the present invention.

FIGS. 11A-11F are diagrams of the instrument of FIG. 10, showingdifferent possible operational configurations of the instrument.

FIG. 12 is a schematic cross-sectional view of a laparoscopic instrumentor cannula holder in accordance with the present invention.

FIG. 13 is a partial view similar to FIG. 12 of the laparoscopicinstrument or cannula holder of that drawing figure.

FIG. 14 is a partial cross-sectional view of another laparoscopicinstrument or cannula holder in accordance with the present invention.

FIG. 15 is a schematic perspective view of a laparoscopic instrument orcannula holder in a collapsed configuration between jaws of a deploymentinstrument.

FIG. 16 is a schematic perspective view of another laparoscopicinstrument or cannula holder in accordance with the invention.

DETAILED DESCRIPTION

The present invention provides laparoscopic instruments and trocarsleeves or cannulas for the performance of laparoscopic proceduresentirely through the umbilicus. The instruments may, however, be used toperform laparoscopic procedures at locations on a patient other than theumbilicus. Referring now in specific detail to the drawings, in whichlike reference numerals identify similar or identical elements, there isshown in FIG. 1 a conventional, prior art laparoscopic instrument—trocarassembly.

As illustrated in FIG. 1, a conventional trocar sleeve or cannula 1 isan essentially straight, hollow instrument, which allows conventionallaparoscopic instruments 3 such as an endoscope of suitable diameter tobe inserted through the conventional cannula 1 and into the abdominalcavity 5 of a patient. Conventional cannulas 1 have a diameter of around2-15 mm. Once the conventional laparoscopic instruments 3 are in place,standard laparoscopic procedures may be performed, such ascholecystectomy, appendectomy, or simple diagnostic laparoscopy.

As shown in FIG. 1, when conventional trocar sleeves or cannulas 1 andconventional laparoscopic instruments 3 are inserted only through theumbilicus of the patient, the close proximity of the instruments to eachother results in the so-called chopstick effect, which is a significantlimitation t the manipulation of conventional laparoscopic instruments 3through conventional trocars 1.

As shown in FIG. 2A and FIG. 2B, an exemplary C-shaped trocar sleeve orcannula 7 is generally an elongated tube having a proximal end 15 and adistal end 17. In one exemplary embodiment the C-shape curve throughends 15, 17 is bent so that each end portion forms an angle ofapproximately 30° with respect to a tangent to the center of the trocarsleeve or cannula 7. However, any angle, which sufficiently reduces thechopstick effect, may be used. Thus, exemplary embodiments with anglesfrom 5-45° may be used. A C-shaped trocar sleeve or cannula 7 may bemade of conventional material as is known in the art. The interiordiameter of a C-shaped cannula 7 is preferably around 5 mm. However, inalternate embodiments the interior diameter of the C-shaped cannula 7may range from 2-15 mm. In one exemplary embodiment, the C-shape isrelatively fixed and does not vary, for example when the cannula has arigid composition. In an alternate exemplary embodiment, the C-shapedcannula 7 is more flexible allowing the surgeon or surgical assistant tobend the cannula 7 changing the angle of the C-shape, for example, viainsertion of an instrument into the cannula.

In an alternative design, trocar sleeve or cannula 7 is made of aflexible material with a memory. Trocar sleeve 7 or cannula 7 may have astraight or linear cylindrical configuration in a relaxed state, i.e.,in the absence of externally applied forces. Sleeve or cannula 7 assumesthe curved or arcuate configuration shown in FIG. 2A upon the insertionthrough the cannula of a laparoscopic instrument shaft with a curved orarcuate section of sufficiently greater rigidity than the cannula.Cannula 7 then bends through the application of external forces to takethe arcuate form shown in FIG. 2A.

FIG. 2C illustrates an exemplary S-shaped laparoscopic instrument 10.The S-shaped laparoscopic instrument 10, has for example, a shaft 10 awith a preformed inherently S-shaped configuration including a proximalcurve 20 and a distal curve 21. Examples of laparoscopic instruments 10which can be formed generally into an S-shape include but are notlimited to scissors, clamps, dissectors, staplers, clip appliers,retrieval bags, and electrocautery instruments. Instruments 10 include amanual actuator 10 b at a proximal end and an operative tip 10 c at adistal end. The S-shaped shaft 10 a may be substantially rigidthroughout. Alternatively, shaft 10 a or a portion thereof, for example,distal curve 21, may be semi-rigid and flexible so that the shaft may bedeformed from the S-shaped configuration to an at least partiallystraightened configuration upon application of deformation forces to theshaft. In the latter case, the shaft is made of a material with a memoryso that the shaft automatically returns to the S-shaped configurationafter relaxation of deformation forces. In another alternative, proximalshaft portion 20 is rigid while distal shaft portion 21 is flexible.Distal portion 21 is flexed into substantially rigid C-shape by alocking mechanism (not separately shown), controlled by actuator 10 b,so the instrument assumes a rigid S-form when needed by the surgeon. Inany event, the S-shape for these instruments can be achieved, forexample, by using conventional manufacturing techniques modified toaccommodate the S-shape contour of the instrument.

As illustrated in FIG. 3, a generally S-shaped laparoscopic instrument10 may be inserted through a C-shaped trocar sleeve or cannula 7. Forexample, the proximal curve 20 of the S-shaped instrument 10 correspondsto the curve of the C-shaped cannula 7. The distal curve 21 of theS-shaped instrument 10 also corresponds to the curve of the C-shapedcannula 7 and when inserted through the C-shaped cannula 7 will be, forexample, entirety within the abdominal cavity 5 of the patient. AC-shaped cannula 7 and S-shaped laparoscopic instrument 10 allows thesurgeon to perform the laparoscopic procedure without making incisionsoutside of the umbilicus. In accordance with the present invention, thesize and curvature of a C-shaped cannula 7 will correspond to the sizeand curvature of an S-shaped instrument 10 and can include any desiredsize.

This arrangement of C-shaped cannula 7 and S-shaped instrument 10eliminates the “chopstick effect” which results from the insertion ofconventional laparoscopic instruments 3 through the umbilicus. Forexample, the proximal curves of the S-shaped instruments 10 and theC-shaped cannula 7 allows the surgeon's hands and the proximal portionsof the instruments 20, including the instruments' handles, to be placedas for apart as is convenient for the surgeon. For example, workspace 9a is created. Movement of the proximal portion of one instrument 20 awayfrom the proximal portion 20 of the other also markedly separates theexposed (e.g. outside the body cavity) shafts of each instrument. Thedistal curve of the S-shaped instrument 21 creates workspace 9 b betweenthe portions of the instruments in the abdominal cavity and redirectsthe distal end of the laparoscopic instrument 10 back toward a targetsite 8, such as an abdominal organ or other abdominal structure or site.

Thus, an S-shaped laparoscopic instrument 10 may be though of as havingfour segments or sections to allow an abdominal procedure to beperformed entirely through the umbilicus and yet overcome the “chopstickeffect” encountered with conventional laparoscopic instruments 3 andcannulas 1. First, the portion outside of the patient's abdominal cavity5 allows sufficient space between the surgeon's hands when manipulatingthe proximal portion of the laparoscopic instruments 10. Second, theportion at or near the umbilicus, which allows a laparoscopic instrument10 to enter the abdominal cavity 5 is in close proximity to one or moreadditional laparoscopic instruments 10 so that all instruments 10 enterthe abdomen through the umbilicus. Third, the portion beyond the secondportion, which creates separation between laparoscopic instruments 10within the abdominal cavity 5. Fourth, the distal end of a laparoscopicinstrument 10 is shaped to point back toward the target abdominal organ,tissue or other site.

Examples of procedures which can be facilitated by the use of C-shapedtrocar sleeves or cannulas 7 and S-Shaped laparoscopic instruments 10include, but are not limited to diagnostic laparoscopy, cholecystectomy,appendectomy, salpingectomy, oophorectomy, treatment of infertility andextrauterine pregnancy, hysterectomy, removal of a section of bowel, avariety of gastric procedures, biopsy of various abdominal organs,including liver, and hernia repair.

The following discussion describes, as an example, a cholecystectomyprocedure as described in FIGS. 2A-C and FIG. 3. It should be noted,however, that many other laparoscopic procedures may be performed usingvarious embodiments disclosed herein. The following description,therefore, is merely illustrative and is not intended to limit thepresent invention to the description given in this example.

A laparoscopic procedure, such as a cholecystectomy, using a curvedC-shaped flexible or rigid trocar sleeve or cannula 7 and S-shapedlaparoscopic instruments 10 is performed with the patient under generalanesthesia. Carbon dioxide gas is insufflated intra-abdominally to 15 mmHg through a 5 mm lateral umbilical incision, using for example, aVERESS™ needle. For example, two curved C-shaped 5 mm cannulas 7 arethen inserted through an incision in the umbilicus. The surgeonoperates, for example, a 5 mm endoscope with one hand and a 5 mmS-shaped laparoscopic instrument 10 with the other, each of which ispassed through a respective cannula 7.

The cannula for the endoscope could be straight so that a conventionalstraight endoscope could be used, the other curved cannula 7 providingseparation between the instruments and the surgeon's hands.Pericholecystic adhesions, if present, are removed by blunt or sharpdissection using an S-shaped dissector to expose the dome of thegallbladder. A 2-0 nylon (or other suitable material) stay suture on aneedle is placed through the abdominal wall immediately below the rightcostal margin at the right anterior axillary line, allowing for superiorretraction of the gall bladder dome. The removal of the adhesions fromaround the gallbladder infundibulum is then continued as necessary. Asecond stay suture is placed through the right flank and then throughthe neck of the gallbladder allowing for lateral retraction to exposethe cystic structures. The cystic duct and cystic artery are dissected,then ligated with clips, utilizing a 5 mm S-shaped clip applier, andthen finally transected with an S-shaped scissors. With continuedretraction from stay sutures, the gallbladder is removed from the liverbed utilizing an S-shaped electrocautery device equipped with a hook,dissecting the gallbladder from medial to lateral and inferior tosuperior direction. The perihepatic area is then irrigated using anS-shaped irrigation/suction device.

The above-described procedure is greatly facilitated by the use ofS-shaped laparoscopic instruments 10 and C-shaped cannulas 7, allowingthe procedure to be performed entirely through the umbilicus while atthe same time reducing or eliminating the “chopstick effect”. Forexample, each of the S-shaped laparoscopic instruments is inserted andremoved from the active curved cannula 7 as needed during the procedureand conflict with the endoscope is avoided. Thus, as a result, improvedcosmesis, reduced operative and post-operative complications, and a lesscomplicated surgical technique are achieved.

FIG. 4A and FIG. 4B illustrate an inflatable cannula holder 30 having,for example, multiple C-shaped trocar sleeves or cannulas incorporatedwithin the unit 30. The lateral wall 34 of the inflatable cannula holderunit 30 may vary from extremely flexible and stretchable when deflated,thus facilitating insertion into the umbilical incision, to somewhatrigid when inflated during the surgical procedure. The inflatable unit30 has, for example, a horizontal upper plate 31 and a horizontal lowerplate 32. Curved or arcuate trocar sleeves or cannulas 33 a, 33 b, and33 c will extend through separate and mutually spaced apertures (notdesignated) in the horizontal upper plate 31 and separate and mutuallyspaced apertures (not designated) in the horizontal lower plate 32 andmay be incorporated within the lateral wall 34. Cannulas 33 a, 33 b, 33c may be rigid or flexible members. One or more straight trocar sleevesor cannulas 33 d may also be provided which traverse holder unit 30 andparticularly upper surface 31 and lower surface 32 thereof. Any givenstraight cannula 33 d may be rigid or flexible. In the latter case, thecannula 33 d may be sufficiently flexible to bend in conformation to agenerally C-shaped section 20 or 21 (FIG. 2C) of laparoscopic instrument10. Shaft 10 a or section 20, 21 thereof is either rigid or has asufficiently rigidity to force the bending of cannula 33 d. One or moreof cannulas 33 a, 33 b and 33 c may similarly be flexible members with amemory tending to return the cannulas to a straight or arcuateconfiguration.

Rigid sections may be inserted or attached around the periphery of thehorizontal upper 31 or lower 32 plate to add stability. The horizontalupper plate 31 and horizontal lower plate 32 may be, for example concaveor straight. At least one and possibly two or more C-shaped trocarsleeves or cannulas 33 a, 33 b, 33 c, (described previously) can beincorporated within the lateral wall 34 of the inflatable unit 30 andare distributed, for example, evenly around the wall 34 of the unit 30.The upper 31 and lower plate 32 are preferably made of a flexibleplastic material or other suitable surgical quality material.

In an alternate embodiment, the inflatable unit 30 has one or moreC-shaped trocar sleeves or cannulas 7 incorporated within its lateralwall 34, and one or more straight cannula 1, also incorporated withinthe inflatable unit's lateral wall 34. The straight cannula mayaccommodate, for example, a straight endoscopic or laparoscopicinstrument, while the C-shaped cannulas 7 can accommodate an S-shapedinstrument 10 as described above. Thus, even where one of theinstruments is relatively straight and passes through a relativelystraight cannula 1, the chopstick effect is still reduced as a result ofthe remaining C-shaped cannulas 7 and S-shaped instruments 10, whichprovide space between the surgeons hands, the proximal portions oflaparoscopic instruments (which includes the straight laparoscope), andthe distal ends of the laparoscopic instruments (which also include thestraight laparoscope).

Inflatable unit 30 may include one or more passageways 40 a and 40 dformed by generally cylindrical webs of resilient material (notseparately designated) connected at opposite ends to upper surface 31and lower surface 32. Upon inflation of unit 30, the webs close thepassageways and, upon insertion of respective cannulas 33 a and 33 d,form a sealed engagement therewith. In one possible mode of use,cannulas 33 a and 33 d are inserted through passageways 40 a and 40donly after placement of unit 30 in an opening formed in a patient andupon inflation of the unit. Alternatively, all cannulas 33 a, 33 b, 33c, 33 d may be disposed within and coupled to unit 30 prior to thepositioning thereof in the patient.

The surgeon may place the inflatable unit 30 through an approximately1.5 to 2.5 cm incision in the umbilicus. The unit 30 is inserted priorto inflation with the C-shaped cannulas 33 a, 33 b, 33 c, for example,parallel and in close proximity to each other. The upper plate 31 willremain outside of the umbilicus while the lower plate 32 is located justinside the abdominal cavity 5. Once the unit 30 is properly positioned,the surgeon or assistant may inflate the unit 30. The unit 30 may beinflated via, for example, a one-directional valve using a syringe orgas line inserted into a narrow hollow tube connected to the unit 30 asis known in the art. The syringe or gas line may be alternativelyinserted directly into a one-directional valve. Thus, means forinflating the unit 30 can similar to the means for inflating aconventional endotracheal tube.

In an exemplary embodiment, the diameter of the inflatable unit 30increases upon inflation. The unit may be inflated to the extent neededfor the particular laparoscopic procedure. By placing the trocar sleevesor cannulas in the lateral walls of the inflatable unit, the surgeon mayposition a trocar sleeves or cannulas, and thus an instrument insertedthrough a cannula, as far away from the other cannulas and instrumentsas possible within the confines of a chosen space such as the umbilicus.In addition, the surgeon may change the position of the cannulas andinstruments within the umbilicus by rotating the inflatable unit 30around its vertical axis. Moreover, the inflatable unit 30 seals theopening of the patient's abdominal cavity 5 to prevent leakage of CO₂from the abdominal cavity.

In an alternate embodiment as shown in FIG. 8, the distance between theupper plate 31 and the lower plate 32 may be reduced, thereby increasingthe ability of the trocar sleeve or cannula 7 to move in relation to thewall of the inflatable unit 30. This design, where the distance between31 and 32 is reduced to form the “plate member,” is preferred. The platemember is located perpendicular to the axis of the cannula holder andanywhere within its walls.

Thus, as an example, the cholecystectomy procedure described above maybe performed using the inflatable unit 30 in conjunction with S-shapedlaparoscopic instruments 10, rather than using separatecannula/instrument arrangements. Once the gallbladder is transected andremoved from the liver bed, it is removed through the 1.5 to 2.5 mmincision along with the inflatable unit 30. If necessary, the initialincision can be extended to remove the gallbladder. Alternatively, thegallbladder may be opened to remove or crush and remove gallstones,facilitating removal of the gallbladder through the umbilical incision.

As shown in FIG. 5A and FIG. 5B, an inflatable unit 70 includes a singleC-shaped trocar sleeve or cannula (not separately designated) having aradially expandable and inflatable balloon-like structure 75incorporated within the hollow lumen 73 of the cannula. A singlelaparoscopic instrument may be inserted within this inflatable unit 70.

Unit 70 may then be inflated to secure the cannula and laparoscopicinstrument together as one movable unit. The inflatable unit 70 may beinflated via, for example, a one-directional valve using a syringe orgas line inserted into a narrow hollow tube 74 connected to the unit 70as is known in the art. The syringe or gas line may be alternativelyinserted directly into a one-directional valve. Thus, means forinflating the unit 70 can be similar to the means for inflating aconventional endotracheal tube. Inflating the inflatable unit 70 alsoserves to seal the abdomen preventing insufflated gas from escapingthrough the lumen of the cannula. The inflatable unit 70 may then bedeflated, the laparoscopic instrument may be removed, and a differentinstrument may be inserted.

While the above description of S-shaped instruments 10 and C-shapedcannulas 7 has been directed to procedures performed entirely throughthe umbilicus, it is to be understood that embodiments of the presentinvention may be adapted for use in other entry sites. Therefore, whenit is desirable to have entry of multiple instruments in a relativelylocalized area, embodiments of the present invention may be used forsuch entry, while reducing or eliminating the so-called “chopstickeffect”. Thus, existing scars or hidden areas such as the pubic hairline or the axillary region may be used as a localized entry site.

As illustrated in FIG. 6, an angulated bi-directional needle 50 isprovided with a first sharp end 51, a second sharp end 52, and asurgical thread 55 attached to the angle 57 of the needle 50. The needle50 has, for example, a total length of around 5-10 cm. The length ofeach segment from the angle to sharp end is roughly equivalent, but neednot be. An acute angle of around 160° is formed by the angulated needle50, however angles 57 ranging from a straight needle, i.e. 180°, to anacute angle 57 of around 90° may be used. The needle is formed out ofsteel or other suitable material. The surgical thread 55, such as 2-0nylon, is attached at the angle 57 of the needle 50.

The angulated needle 50 simplifies suture delivery through thegallbladder or other abdominal structure. For example, the first sharpend 51 of the needle 50 is inserted through the body wall by thesurgeon. The needle 50 is then grasped within the abdominal cavity 5 bya laparoscopic instrument under endoscopic guidance and is pulled towardthe organ of interest. With the second sharp end 52 leading, a stitch isplaced through the abdominal structure of interest. The second sharp end52 is then delivered through the abdominal wall.

The angulated bi-directional needle 50 allows delivery of a switchwithout changing the orientation of the sharp end as would be necessaryif a needle with only one sharp end is used. Changing the direction ofthe needle with one sharp end to 180 degree laparoscopically might betechnically challenging.

An alternative exemplary embodiment of a angulated needle is shown inFIG. 7. In this embodiment the angulated needle 60 has, for example, along segment 61 with one sharp end 62 on one side of the angle 65. Theneedle 60 has a blunt short segment 67 on the other side of the angle65. Thread 68 is attached to the end of the blunt short segment 67.

The angulated needle 60 allows penetration through the body wall as astraight needle. The needle 60 is inserted into and through the wall ofthe gallbladder. The needle is then flipped 180° and delivered backthrough the abdominal wall. The angulated needle 60 can be used toreposition a gall bladder or other structure during a laparoscopicprocedure by, for example, puling or relaxing the suture, whicheliminates or reduces the need for the insertion of one or moreadditional cannulas and laparoscopic instruments for that purpose. Theangulation of the angulated needle 60 also reduces the chalice ofiatrogenic injury to surrounding structures by allowing the needle 60 tobe flipped and then delivered back through the abdominal wall prior tocontacting surrounding abdominal structures.

As illustrated in FIG. 9, a stand-alone laparoscopic medical instrumentinsertable through a laparoscopic trocar sleeve or cannula comprises anelongate shaft 80 formed of a plurality of a plurality of rigidcylindrical segments including a middle segment 82, three proximal endsegments 84, 86, and 88, and three distal end segments 90, 92 and 94.During a laparoscopic procedure utilizing the instrument of FIG. 9,middle segment 82 transverses a laparoscopic cannula, trocar sleeve orinstrument holder described herein, while proximal end segments 84,86and 88 are located outside the patient and distal end segments 90, 92,and 94 are located inside the patient. An operative tip 96 is disposedat one end of the shaft 80, more particularly at a free end of distalend segment 94, and actuator handles or grips 98 are disposed at anopposite end of the shaft, more particularly at a free end of proximalend segment 88. Actuator handles 98 are operatively connected tooperative tip 96 via shaft 80 for controlling the operation of the tip.

Proximal end segments 84, 86 and 88 form a proximal shaft portion 100that is independently bendable to form, for example, a C shapedconfiguration. Proximal end segments 84, 86, and 88 are connected to oneanother via joints or articulations 102 and 104 and to middle segment 82via a joint or articulation 106.

Distal end segments 90, 92 and 94 form a distal shaft portion 108 thatis independently bendable to form, for example, a C shapedconfiguration. Distal end segments 90, 92, and 94 are connected to oneanother via joints or articulations 110 and 112 and to middle segment 82via a joint or articulation 114.

Operative tip 96 may be rotatable about a longitudinal axis 115. Furtherrotational capability may be provided by including a joint 116, 118, 120along distal end segments 90, 92 or middle segment 82, where relativerotation of proximal and distal parts is effectuated about alongitudinal axis of the respective segment.

Proximal end portion 88 is provided with rotary actuators or knobs 122for modifying the angles between adjacent distal end segments 90, 92,94, for rotating operative tip 96 relative to distal end segment 94about axis 114, and for implementing the longitudinal-axis rotation atjoints 116, 118, and/or 120. Wing-nut-type clamps 124 may be provided atknobs 122 for releasably locking those actuators to maintain the anglesbetween adjacent distal end segments 90, 92, 94, the rotary position ofoperative tip 96, and the longitudinal-axis rotation at joints 116, 118,and/or 120.

Clamping elements 126, 128, 130 may be provided at the articulations orjoints 102, 104, 106 for locking the relative positions of middlesegment 82, and proximal end segments 84, 86, 88. Alternatively, furtherknobs and wing-nut clamps (not shown) may be provided at the proximalend of the instrument for changing the angles between pairs of adjacentsegments 82, 84, 86, 88.

During a laparoscopic surgical procedure, the axial position of theoperative tip 96 may be adjusted by sliding the laparoscopic instrumentof FIG. 9 into and out of the patient, for example, by modifying theposition of the middle segment 82 relative to the respective cannula orinstrument holder aperture. In addition, the axial position of operativetip 96 may be changed by adjusting the configuration of distal endportions 90, 92, 94 relative to one another. Strongly arcedconfigurations have a shorter axial extent than configurations with moreshallow arcs.

Further degrees of freedom in the positioning of operative tip 96relative to a surgical site are provided by the rotatability ofoperative tip 96 about the axis 114 and the rotatability at joints 116,118, 120. The positional adjustability provided by articulations orjoints 110, 112, 114 greatly enhances the practical capabilities of theinstrument.

FIG. 10 depicts another stand-alone laparoscopic medical instrumenthaving a shaft 132 insertable through a laparoscopic trocar sleeve orcannula. Shaft 132 has a continuously flexible proximal end portion orsegment 134, a rigid straight middle portion or segment 136, and adistal end portion 138. Proximal end portion 134 and distal end portion136 are connected to Opposite ends of middle portion 136 via respectivearticulations or joints 140 and 142, so that the proximal end portionand the distal end portion arc laterally swingable relative to themiddle portion, as indicated by dual headed arrows 144 and 146. Middleportion 136 constitutes about one-third of the total length of shaft132.

Shaft 132 is provided at a proximal end, i.e., at the free end ofproximal end portion 134, with a pair of hand grip actuators 148, and isfurther provided at a distal end, i.e., at the free end of distal endportion 138 with an operative tip 150 such as scissors, a forceps, aclamp, a cauterizing element, etc. Operative tip 150 is rotatable abouta longitudinal axis 152 relative to the end of distal end portion 138,as indicated by a bidirectional arrow 154. As indicated by anotherbidirectional arrow 157, proximal end portion 134 and distal end portion138 may be rotable relative to one another about a longitudinalinstrument axis 156, owing to a rotable joint 158 exemplarily providedalong middle portion 136.

Distal end portion 138 includes two segments or sections 160 and 162pivotably connected to one another via an articulation or joint 164, asindicated by a dual headed arrow 166. Distal-most section 162 iscontinuously bendable along its length into an infinite number ofsmoothly curved generally C-shaped configurations, as indicated by anarrow 168. The more proximal section 160 may be rigid and linear or,alternatively, also continuously flexible along substantially its entirelength and formable into a multitude of smoothly arced generallyC-shaped configurations.

Proximal end portion 134 is provided along a linear proximal section(separately labeled) with a plurality of actuator knobs 170 and lockingelements 172 for controllably modifying (a) the degree of curvature ofproximal end portion 134 and distal end portion 138, particularlydistal-most section 162, (b) the angles between portions 134 and 136 andportions 136 and 138, (c) the angle between sections 160 and 162, (d)the degree and direction of rotation of operative tip 150 about axis152, and (e) the relative angular position of proximal end portion 134and distal end portion 138, as determined by the operational status ofjoint 158. By way of illustration, a modified position and curvature ofdistal-most section 162 is indicated in FIG. 10 at 174. A modifiedposition of proximal section 160 and a corresponding modified curvatureof distal most section 162 are indicated in phantom at 176. An alternateposition of proximal end portion 134 with respect to middle portion 136is shown in phantom at 178.

FIGS. 11A-11F depict additional possible positional and curvatureconfigurations of the instrument of FIG. 10, particularly distal endportion 138.

During a laparoscopic surgical procedure, the axial position ofoperative tip 150 may be adjusted by sliding the laparoscopic instrumentof FIG. 10 into and out of the patient, for example, by modifying theposition of middle portion 136 relative to the respective cannula orinstrument holder aperture. In addition, the axial position of operativetip 150 may be changed by adjusting the configuration of distal endportion 138, as depicted in FIGS. 11A-11F. Strongly arced configurations(FIGS. 11B and 11C) have a shorter axial extent than configurations withmore shallow arcs (FIGS. 11A, 11E). Further degrees of freedom in thepositioning of operative tip 150 relative to a surgical site areprovided by the rotatability of operative tip 150 about axis 152 and therotatability at joint 158.

One or more of the actuator mechanisms including knobs 170 and lockingelements 172 may be operatively connected to shaft 132 for bendingdistal section 162 (and optionally section 160) in a direction out ofthe plane of the drawing sheet.

Where proximal portion 134 of shaft 132 assumes a first C-shapedconfiguration in response to operation of a respective one of the knobs170 and distal portion 138 (or 162) of the shaft assumes a secondC-shaped configuration in response to operation of a second one of theknobs 170, the C-shaped configurations may face opposite sides of theshaft, thus forming shaft 132 into a generally S-shape.

As depicted in FIG. 12, a holder 180 for cannulas and laparoscopicsurgical instruments such as those discussed above the reference toFIGS. 9-11F indicates a plate member 182 having a surrounding orperimetric edge 184 and a wall 186 surrounding the plate member. Wall186 is provided with a plurality of anchoring elements such as eyelets187 or hooks 189 for securing the holder 180 to a patient via suturethread.

Wall 186 is connected to a plate member 182 all along edge 184. Wall 186has a longitudinal axis 188, with plate member 182 extendingsubstantially transversely to that axis. Plate member 182 is providedwith a plurality of separate and mutually spaced apertures or portmembers 190, 192 for receiving respective elongate laparoscopicinstruments 194 and 196. Instrument 194 is configurable to have anS-shaped shaft 198 and may specifically take the form of the instrumentsdiscussed with reference to FIGS. 9 and 10-11F. Instrument 196 is afiberoptic instrument including a camera 200 in the form of a chargecoupled device and a bendable shaft 202. Shaft 202 has a proximal endportion 260 and a distal end portion 262 that may be independentlyflexed into continuous smooth C-shaped configurations as shown in thedrawing. Alternatively, shaft 202 may be substantially identical toshaft 132 of the instrument shown in FIG. 10. The rotational capabilitydiscussed above with reference to operative tip 150 and joint 158 may beomitted from laparoscope 196. Laparoscope 196 has an operative tip 264provided with the usual illumination aperture and imaging lens (neithershown). Actuators are omitted from the depiction in FIG. 12 ofinstruments 194 and 196 for purposes of simplicity. An actuator forcontrolling the operative tip 264 of laparoscope 196 may take the formof conventional controls for illumination and CCD operation, where a CCDis located at the operative tip of the device.

Holder 180 is an inflatable unit, both plate 182 and wall 186 being atleast partially hollow for receiving a pressurizing fluid such as air.To that end, a tube 204 is connected to holder 180 for the delivery ofair from a pressure source such as a syringe (not illustrated). A valve206 is provided on tube 204. A second tube 208 with a valve 210 isconnected to holder 180 for providing a channel for the conveyance of aninsufflation gas such as carbon dioxide from a reservoir thereof (notshown) to the patient. An aperture 212 is provided along an innersurface 214 of wall 186 for enabling the delivery of the illustrationgas to the patent via tube 208.

Wall 186 has a height dimension H1 at least as great as, and preferablysubstantially greater than, a height dimension 112 of plate member 182.Wall 186 has two end portions 216 and 218 extending as endless orannular flanges to plate member 182. Plate member 182 is located towardsan upper end of wall 186, plate member 182 forming a shallow cup shapeand a deep cup shape with flanges 216 and 218, respectively.

Wall 186 has inner diameters D1 and D2 of the free ends flanges 216 and218, opposite plate member 182. These inner diameters D1 and D2 arelarger than a diameter D3 of plate member 182, which is the innerdiameter of wall 182 at the plate member. Consequently, cannula andinstrument holder 180 has a flared or tapered profile on each side ofplate 182. This flared or tapered shape may exhibit a curved or arcedprofile as shown in the drawing.

FIG. 13 is a cross-sectional view of holder 180 similar to FIG. 12, withlaparoscopic instruments 194 and 196 removed to show possible valves 220and 222 included in port members 190, 192. Valves 220 and 222 are notpart oldie present invention. Any known valve structure may be used inport members 190, 192.

It is possible for port members 190, 192 to be disposed entirely withinplate member 182. In that case, the port members incorporate flat valvesin the form of flexible, horizontally located membrane with openings forthe passage of laparoscopic instruments.

As illustrated in FIG. 14, a flexible plate member 224 of a cannula andinstrument holder 226 similar to that of FIGS. 12 and 13 has separateand mutually spaced apertures 3228 provided with rigid port membranes orcannulas 230 serving in part to elongate the apertures. Port members orcannulas 230 have a curvilinear or arced shape along their longitudinaldimensions and have flanges 232 and 234 that extend outside of platemember 224. Plate member 224 has a height H3 in a direction parallel toan axis of 236 of the cannula and instrument holder, which is at leastas great as heights H4 and H5 of extension flanges 232.

Cannula and instrument holder 0226 has a side wall 237 that issubstantially rigid in a region about plate member 224 and flexible atleast in a distal flange region (inside the patient) spaced from platemember 224. Such a design facilitates cannula insertion in the abdominalwall opening and overall structural integrity of the system while underdeforming external pressure (rigid part), and provides an improveddegree of freedom, particularly in the lateral planes, within the system(flexible part).

Plate members 182 and 224, as well as walls 186 and 238 of holders 180and 226 are flexible, but can acquire a semi-rigid form upon tillingwith inflation fluid. The flexibility of the holders 180, 226 means thatthese devices can be rolled or folded into a compact deflatedconfiguration for insertion into the umbilicus or other abdominalaperture. FIG. 15 shows such a compacted insertion configuration of aninstrument holder 240 having port members 242. For assisting in thedeployment of the instrument holder 240, tongs 244 may be used. Tongs244 have a pair of handles 246 and a pair of substantially cylindricaljaw elements 248. The compacted instrument holder 240 is held betweenjaw elements 248 for insertion into the umbilicus. The compacted holderis held by a finger or instrument in place, while tongs 244 are openedslightly (arrow 247) and pulled (arrow 249) to separate jaw elements 248from the holder 240. The holder 240 is then inflated in the umbilicus tothe use configuration.

FIG. 16 depicts another instrument or cannula holder 250 for theinsertion of multiple laparoscopic instruments into a patient through asingle aperture in the abdominal wall of the patient. Instrument orcannula holder 250 includes a flared annular body member 252 provided aton end with a plurality of tapered or funnel-shaped introduction ports254. Ports 254 include apertures 256 for the introduction oflaparoscopic instruments as discussed hereinabove.

More particularly, the tapered or funnel-shaped port elements 254 eachdefine a plurality of cross-sectional diameters D and each of saidplurality of tapered funnel-shaped port elements 254 are connected tothe flared annular body member 252 and extend proximally in a commondirection therefrom, as indicated by the arrow 300. The taper of each ofthe tapered funnel-shaped port elements 254 decreases the plurality ofcross-sectional diameters D in the proximal direction indicated by arrow300.

The annular body member 252 has a C-shaped flared profile 302 along alongitudinal axis 304. The annular body member 252 defines a proximalaperture 306 and a perimeter 308. The plurality of tapered funnel-shapedport elements 254 each defines a distal aperture 310 and a perimeter312. At least a portion 312′ of the perimeter 312 of the plurality oftapered funnel-shaped port elements 254 is connected to the perimeter308 of the proximal aperture 306 of the annular body member 252.

A remaining portion 314 of the perimeter 312 of at least two of theplurality of tapered funnel-shaped port elements 254 are connected toeach other and intersect at a common point of intersection 316 generallycoinciding with the center of the proximal aperture 306 of the annularbody member 252. The distal apertures 310 defined by the two or moretapered funnel-shaped port elements 254 span the entire proximalaperture 306 defined by the annular body member 252.

The term “laparoscopic medical instrument” is used herein to denote allinstruments utilizable in the performance of a laparoscopic medicalprocedure, including surgical instruments and laparoscopes.

While several exemplary embodiments of laparoscopic instruments andcannulas for the performance of laparoscopic procedures entirely throughthe umbilicus have been described herein, it is to be understood thatvariations may be made in the laparoscopic instruments and cannulaswithout departing from the spirit and scope of the present invention asdefined by the appended claims.

1-74. (canceled)
 75. A method of laparoscopic surgery comprising thesteps of: grasping an instrument holder assembly having an insertionconfiguration for at least partial insertion of said holder assemblythrough an incision in a patient for at least partial insertion of saidholder assembly into a patient cavity, and an in use configuration foruse of said instrument holder assembly for access to said patientcavity, said instrument holder assembly radially compressed into acompact configuration for the insertion of said holder assembly at leastpartially through the incision in a patient, the radially compressedcompacted instrument holder assembly defining an outer peripheralsurface; and inserting said radially compressed compacted instrumentholder assembly at least partially through said incision, wherein thestep of grasping said radially compressed compacted instrument holderassembly is performed by retaining the outer peripheral surface of theradially compressed compacted instrument holder assembly via a graspinginstrument.
 76. The method of laparoscopic surgery as defined in claim75, further comprising the steps of: maintaining the compactedinstrument holder assembly in place in the incision; and opening thegrasping instrument slightly to enable movement of the graspinginstrument from the compacted instrument holder assembly.
 77. The methodof laparoscopic surgery as defined in claim 76, further comprising thesteps of: approximating the grasping instrument in a direction proximalto a user; and separating the grasping instrument from the compactedinstrument holder assembly.
 78. The method of laparoscopic surgery asdefined in claim 75, wherein the retaining of the outer peripheralsurface of the radially compressed compacted instrument holder assemblyvia a grasping instrument is performed by retaining the outer peripheralsurface of the radially compressed compacted instrument holder assemblyvia at least one of a pair of tongs.
 79. The method of laparoscopicsurgery as defined in claim 78, wherein the retaining of the radiallycompressed compacted instrument holder assembly via at least one of apair of tongs is performed via a pair of tongs that comprises: a pair ofhandles pivotably joined to each other, the handles defining proximaland distal ends; and a pair of jaw elements configured and disposed oneon each of the distal ends of the handles to enable retention of saidradially compressed compacted instrument holder assembly.
 80. The methodof laparoscopic surgery as defined in claim 79, further comprising thesteps of: maintaining the compacted instrument holder assembly in placein the incision; and opening the pair of tongs slightly to enablemovement of the jaw elements from the compacted instrument holderassembly.
 81. The method of laparoscopic surgery as defined in claim 80,further comprising the steps of: approximating the pair of tongs in adirection proximal to a user; and separating the pair of tongs from thecompacted instrument holder assembly.
 82. The method of laparoscopicsurgery as defined in claim 79, wherein the step of retaining theradially compressed compacted instrument holder assembly via the pair oftongs is performed wherein the jaw elements are cylindrically shaped andgrasp the radially compressed compacted instrument holder assemblytherebetween.